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Sutureless valves

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Sutureless Aortic Valves Hani K. Najm MD, Msc, FRCSC,, FACC, FESC Head of Cardiac Surgery King Abdulaziz Cardiac Centre National Guard Health Affairs Riyadh, Saudi Arabia

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Sutureless valve

 Sutureless fixation of the valve onto a debris free aortic

annulus combines the advantages of open surgical AVR and TAVI.

 Sutureless valve available:  Perceval S  Intuity valve system  3f enable valve.


Advantages of sutureless vavlve  Complete excision of the diseased valve.  Anatomical tailoring to individual patient anatomy.  Atraumatic introduction with minimal or no crimping of the the

valve leaflets allowing more predictable long term outcomes  Valves are self anchoring ( no need for sutures), self expanding for

easy implantation and good visibility  Shorter CPB  Permits minimally invasive cardiac surgery procedures while

delivering gold standard surgical outcome.


Perceval S


Perceval S – the design Outflow Ring: at the STJ level

Sinusoidal Struts: anchoring into Valsalva Sinuses Straight commissural struts: supporting the valve Inflow tissue ring 7


Perceval S – Design Features  Using well known biological valve design – more

than 20 years of Sorin pericardial tissue valve expertise  Innovative sutureless anchoring into the aortic

root anatomy by a unique anchoring system made of shape memory alloy  All non-biological surfaces coated with

Carbofilm™ (highly biocompatible carbon coating) 8


Perceval S – collapsing system •

A minimal and atraumatic collapsing device ensures creaseproof valve tissue Low profile (12 mm) ideal for small aortic roots and annuli Collapsed Outflow Ring Valve Leaflets are creaseproof Collapsed Inflow Ring

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Perceval S – collapsing system Valve Leaflets are creaseproof

Collapsed Outflow Ring Collapsed Inflow Ring

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Perceval S Clinical Experience Enrolment Status Patients No Follow Up Indications Endpoints Size Surgical Approach

Complete Apr 2007-Feb 2008

Complete Jan 2009-Jan 2010

Ongoing Feb 2011

30 pts – 3 EU centres

150 pts – 9 EU centres

570 pts implanted 26 EU centres

to 5 yrs ongoing

to 5 years ongoing

Ongoing

Patients ≥ 75years

Patients ≥ 75years

Feasibility Safety 30 days

Safety & Effectiveness months

S-M

S-M

S–M–L

Median sternotomy

Median & Mini Sternotomy

Median & Mini Sternotomy

3-6

Patients ≥ 65years Safety & Effectiveness 12 months

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Pooled PILOT and PIVOTAL Trial – Study design Primary Objective Study Design Patient population Major Inclusion Criteria Major Exclusion Criteria

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Safety and effectiveness of the Perceval S valve

Prospective, Multicentre, European, Non-randomized

Adult patients (>75 yrs) with aortic stenosis or stenoinsufficiency • Patients > 75 years old • NYHA Class III or IV and Log Euroscore > 5% • Aortic annulus in the range 19 - 23 mm

• Pure aortic insufficiency • Congenital bicuspid aortic valve • Concomitant procedures other than CABG or septal miectomy • Subjects with AMI within 3 months • Subjects with aortic root enlargement


• Clinical experience on 659 patients • Over 4 years follow-up • 3 consecutive trials in 26 Centers in 8 European Countries • Surgical access: median and mini-sternotomy • Age: ≥ 65 years • Mean STS score: 9.6 • Available sizes: S- M – L


Perceval S - Indications

AVR patients ideal for a Perceval S:

 Small Aorta  Small Annuli  Calcified Aortic root Compromised pre-

 Higher-risk

operative contractile function

 Respiratory

patients

requiring concomitant procedure (CABG) (COPD)

disorders


Major Inclusion Criteria

• Adult patients (>75 yrs; >65 yrs from 2010) with aortic stenosis or steno-insufficiency • Aortic annulus in the range 19 – 25 mm

Major Exclusion Criteria

• Pure aortic regurgitation • Congenital bicuspid aortic valve • Subjects with aortic root enlargement


Demographic Data Implant period

April 2007 – September 2011

Mean age

79 ± 5 yrs (63-92 yrs)

Gender (Female)

67.7%

EuroScore (%)

11.27 ± 8.44

STS score (%)

9.60 ± 5.85

Age distribution

More than 40% of pts older than 80 years


Diagnosis

Concomitant procedures

Surgical approach


Median Sternotomy Isolated AVR

Complex AVR

Mean±SD

Mean±SD

X-clamp (min)

31.0 ±11.0

52.2 ±24.2

Pump time (min)

51.3 ±19.8

80.6 ±34.5

Mini-Sternotomy Isolated AVR Mean±SD

X-clamp (min)

37.7 ±12.2

Pump time (min)

65.6 ±21.4


80

Implanted size

70

60

50

g H m

Mean Gradient Peak Gradient

40

30

20

10

0 Preoperative

Discharge/1 month

3-6 months

12 months

3 years


Perceval S experience

LV mass and LV mass indexed by visit - 3y 280

160 143,6

260 258,5

140

130,1 122,5

240

121,5 120

232,1

220

214,2 200

88,8

100

g

80 180

g/m ²

207,4 LV mass LV mass indexed 60

160 152,4

140

40

20

120

100

0 Preoperative

15/04/13

Discharge/ 1 month

3-6 months

12 months

3 years


 No thrombosis  No post-operative migrations  No SVD  Early cardiac mortality 1.6% (late 0.6%)  Major stroke 1.9% (late 0.6%)  Major PVL 1.1% (late 0.6%)


Perceval S clinical benefits Perceval S significantly reduces the mortality

Brown JM et al; J Thorac Cardiovasc Surg 2009 Jan;137(1):82-90. Martyn T et al. Circulation. 2010;122:62-69 24


Perceval S clinical benefits with economic relevance Clinical Outcome Perceval S

C-AVR

TAVI

Length of stay

11

11.8

18

(days) ICU stay

2.1

2.7

4.5

(days)

ICU Hospital Stay /day = 1164 € (Germany) Ward Hospital Stay /day = 724 € (Italy) Perceval S Sutureless Valve – Special Indications; Fischlein, EACTS 2011

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The clinical experience on 659 patients up to 4 years follow-up shows the Perceval S : 

Makes AVR a reproducible and easy procedure

- Clear and rapid

Implant Technique - Minimally invasive AVR can gain broader access

Minimizes Aortic Cross Clamping Time

Enhances hemodynamic performances

Delivers excellent clinical outcomes

It represents our choice for medium - high risk patients


INTUITY VALVE SYSTEM


Indications and Contraindications INDICATIONS  For patients whose aortic

valve disease is sufficiently advanced to warrant replacement of their native valve  Also intended for re-do

patients in which the previously implanted prosthesis is excised and replaced with the EDWARDS INTUITY valve

CONTRAINDICATIONS • Pure aortic insufficiency • Aneurysms of the aortic root or ascending aorta • History of active endocarditis within 3 months of scheduled surgery Warning: The safety and effectiveness of the EDWARDS INTUITY valve has not been established for patients with a congenital bicuspid or unicuspid aortic valve, because it has not been studied in these populations


EDWARDS INTUITY Valve System Aortic Valve

• Sterilized in glutaraldehyde • Valve is inverted in the jar to facilitate attachment of the delivery system

Delivery System

• Ethylene oxide (ETO) sterilized • Components secured on a plastic card • Single barrier peel pouch

Inflation Device

• Ethylene oxide (ETO) sterilized • Secured in a tray • Single barrier peel


Procedure Review

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Examples of Standard Aortotomies

Transverse

Hockey Stick

Lazy S


Leaflet Excision


Annular Debridement ď “

Annulus with calcification

Calcification removed

• Debride calcium from the annulus to ensure proper seating of the valve and to avoid damage to the valve leaflets


Anatomic and Valve Considerations For Sizing

Supra-annular Intra-annular Sub-annular


Sizing

Click to show this part of the sizing process

Visual assessment of native annulus to determine approximate size

Select appropriate sizer

Size the annulus choosing the largest diameter barrel end that is a snug fit in the annulus

If the annular dimension is assessed to fall between valve sizes, selection of the smaller size valve is recommended


Guiding Suture Placement in the Annulus

 Conventional suture Non-Everting

techniques, such as noneverting mattress, figure of eight or simple can be used with this valve

 Three annular sutures equally

spaced and placed in the middle of each sinus to guide the valve onto the annulus

Figure of Eight

 Non-pledgetted, braided

sutures are recommended


Guiding Suture Placement on the Valve 

First inspect the valve before implant for evidence of extreme temperature exposure or other damage

Secure valve by holding distal handle

Place each suture through the sewing ring in positions corresponding to the annular suture positions

Avoid inserting too deeply through sewing ring


Lowering Valve to the Annulus • Lower valve onto the annulus using the distal handle

• Pull up on guiding sutures to maintain tension


Valve Seating ď “

Tilt valve left to right to ensure ideal seating

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Confirm sutures on sewing ring and sutures in the annulus align properly

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Once seated, maintain downward pressure on distal handle


Use of Snares

Thread guiding suture through snare or tourniquet using a snare hook

Pull upward on guiding suture and anchor distal end of snare with hemostat

Repeat for all guiding sutures


Valve Inspection

Confirm valve seating

Confirm valve position

Close the aortotomy


Key results One-year follow-up details


Key results One-year follow-up details


Key results Safety endpoints: PVL


Step 3: Key results Procedure times


Step 3: Key results Procedure times


Step 3: Key results Hemodynamic performance at 1 year


Key messages to deliver

 Safe, feasible, and efficacious  Offers flexibility of approach: full, upper mini-sternotomy  Reduced aortic crossclamp and cardiopulmonary bypass

times  Early hemodynamic performance was excellent and

remained so up to 1 year


King Abdul Aziz Cardiac Center experience  22 Perceval implants (first out of Europe implants)  Mean age 75 years  Concomitant procedure in 13  1 mortality unrelated to valve  Post op gradient mean of 8 mmHg  No paravalvular leak  4 Intuity valves (first out of Europe implants)  Mean age 65 years  No mortality or morbidity  Post op gradients mean of 9 mmHg


Conclusions

 Sutureless aortic valve replacement is safe and has excellent

early and mid outcome  Perfectly suitable for small aortic roots and poor ejection

fraction patients  Reduces ischemic and pump time  Long term outcome is still awaited.


SHA24/074004